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Clinical Trials/NCT04747002
NCT04747002UnknownPhase 2

Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "DSP-7888" for Acute Myeloid Leukemia Patients.

Osaka University1 site in 1 country100 target enrollmentStarted: June 12, 2020Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Enrollment
100
Locations
1
Primary Endpoint
Relapse-free survival
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological complete remission (CR). DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize Wilms Tumor Gene 1 (WT1) peptides.

Detailed Description

This study is an investigator-initiated clinical trial (Phase II) using DSP-7888 for acute myeloid leukemia patients with 1st hematological CR. DSP-7888 is a novel cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides. Primary endpoint is relapse-free survival, and 2nd endpoint is hematological relapse-free survival, overall survival and adverse event.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •acute myeloid leukemia defined by World Health Organization (WHO) 2016 classification
  • •favorable or intermediate risk based on European Leukemia Net (ELN) 2017 risk classification
  • •1st hematological after chemotherapy
  • •Human Leukocyte Antigen (HLA)-A*02:01, 02:06, 24:02
  • •20-80 years old
  • •Eastern Cooperative Oncology Group (ECOG) performance Status 0-2
  • •within 35 days after White Blood Cell (WBC) and Neutrophil recovers over 1500 and 500, respectively
  • •sufficient organ function as below within 7 days
  • •(1) Neutrophil : >= 1000 (2) Cr : >= 3.0mg/dl (3) Aspartate aminotransferase (AST), Alanine transaminase (ALT) : 5 x the upper limit of normal (ULN) for the reference lab (4) Percutaneous oxygen saturation (SpO2): >= 95% 9) patients who agree contraception until 6 months after the last injection 10) non-candidate for hematopoietic stem cell transplantation.
  • •illegible for hematopoietic stem cell transplantation (HSCT)
  • •lack of appropriate donor
  • •patients who don't select HSCT at the 1st hematological complete remission (hCR) timing

Exclusion Criteria

  • •multiple primary cancer
  • •autoimmune disease
  • •usage of investigational or unapproved drug within 28 days
  • •severe organ failure
  • •Human Immunodeficiency Virus (HIV) antibody / Hepatitis B surface (HBs) antigen / Hepatitis C Virus (HCV) antibody positive
  • •pregnant woman
  • •lactating woman
  • •under treatment against active infection
  • •difficult to enroll because of mental problem
  • •other reasons which investigator judge appropriate for enrollment

Arms & Interventions

Administration Group

Active Comparator

Patients who are injected with DSP-7888.

Intervention: DSP-7888 (Drug)

Outcomes

Primary Outcomes

Relapse-free survival

Time Frame: 2 year

Secondary Outcomes

  • Overall survival(2 year)
  • Hematological relapse-free survival(2 year)
  • Adverse event(2 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yoichi Yamamoto

Professor

Osaka University

Study Sites (1)

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